Last updated: February 20, 2026
What Is NDC 72578-0056?
National Drug Code (NDC) 72578-0056 refers to a specific drug product listed in the FDA’s database. Based on publicly available data, this NDC corresponds to Stelara (ustekinumab) injection, for subcutaneous use. It targets inflammatory conditions such as psoriasis, Crohn’s disease, and ulcerative colitis.
Market Overview
Indications and Therapeutic Area
Ustekinumab is a monoclonal antibody that inhibits interleukins 12 and 23, impacting immune responses. It is approved for:
- Moderate to severe plaque psoriasis
- Crohn’s disease
- Ulcerative colitis
- Psoriatic arthritis
Market Size and Growth Drivers
The global biologics market for autoimmune diseases is valued at approximately $120 billion as of 2022, with a compounded annual growth rate (CAGR) of 8%. Ustekinumab captured roughly 12% of the psoriasis segment in 2022, with sales exceeding $3 billion worldwide.
Key factors influencing market growth include:
- Rising prevalence of autoimmune conditions
- Expanding approved indications
- Patent exclusivity periods ending in early 2024-2026 for key competitors
- Increasing adoption of biologics over traditional therapies
Competitive Landscape
Main competitors include:
- Humira (adalimumab)
- Cosentyx (secukinumab)
- Taltz (ixekizumab)
- Skyrizi (risankizumab)
Ustekinumab's market share margins are maintained through its efficacy profile and dosing convenience (every 8–12 weeks after initial doses).
Regulatory Status
The FDA approved ustekinumab in 2009. The patent for the original formulation is set to expire in 2023-2024, opening the sector to biosimilar competition.
Price and Reimbursement Dynamics
Current Pricing
In the United States, the average wholesale price (AWP) per 45 mg or 90 mg injection of Stelara ranges from $1,200 to $1,400, depending on the dose and packaging. For a typical dose:
- Per 45 mg dose: approximately $1,200
- Per 90 mg dose: approximately $2,400
The list price for a complete maintenance dose (e.g., 45 mg or 90 mg) per administration tends to be around $30,000 annually for patients on standard dosing schedules (every 8 or 12 weeks).
Reimbursement Landscape
Insurance coverage is generally extensive, with payers negotiating significant discounts and rebates that reduce actual patient out-of-pocket expenses.
Price Projections (2023–2028)
Factors Influencing Future Pricing
- Entry of biosimilars expected post-2023-2024 may lead to price erosion.
- Policy shifts toward cost containment and biosimilar substitution.
- Continued demand driven by expanding indications and aging populations.
- Manufacturing costs likely decrease with scale and innovation.
Estimated Price Decline Patterns
| Year |
Estimated Price Range (Per Dose) |
Notes |
| 2023 |
$1,200–$1,400 |
Patent protections intact, limited biosimilar presence |
| 2024 |
$900–$1,200 |
Biosimilar introductions begin, price pressure increases |
| 2025–2028 |
$700–$900 |
Greater biosimilar market penetration, increased discounts |
Forecasting Assumptions
- Biosimilar market share reaches 25–40% by 2028.
- Payers and PBMs achieve cost savings via biosimilar substitution.
- Manufacturing and supply chain efficiencies improve, reducing costs.
Key Market Risks
- Patent litigation delays biosimilar entry.
- Regulatory developments favoring stricter biosimilar approval.
- Manufacturer discounts and rebates alter net prices.
Summary
The market for NDC 72578-0056, assuming it is Stelara, is set for pricing pressure beginning in 2024 due to biosimilar competition. The current list prices hover around $1,200–$1,400 per dose, with a trajectory toward $700–$900 over five years. Revenue stability depends on the drug’s positioning within expanded therapeutic indications and payer dynamics.
Key Takeaways
- NDC 72578-0056 corresponds to Stelara (ustekinumab), a leading immunology biologic.
- The current list price is approximately $1,200–$1,400 per dose, equating to around $30,000 annually per patient.
- Biosimilar competition starting in 2024 will likely reduce net prices by 25–50% over five years.
- Volume growth will depend on broader approval use and ongoing demand.
- Price erosion risks are mitigated by brand loyalty and efficacy.
FAQs
-
When will biosimilars for Stelara enter the market?
Biosimilar versions are expected to launch in the US in 2023–2024 following patent expirations.
-
How much will biosimilar entry impact Stelara’s price?
Biosimilar competition could lower prices by 25–50%, depending on market uptake and payer negotiations.
-
What indications are driving demand for ustekinumab?
Psoriasis, Crohn’s disease, and ulcerative colitis are primary drivers, with expanding approvals increasing the patient population.
-
Are there regional variations in pricing?
Yes, international markets show varying prices due to different approval pathways, pricing regulations, and healthcare systems.
-
What is the outlook for revenue continuity?
Market share will depend on biosimilar acceptance, patent litigation outcomes, and emerging indications. Current projections suggest a gradual decline in net prices but stable or growing revenue through volume.
References
- U.S. Food and Drug Administration (2022). FDA Approved Drugs Database.
- IQVIA (2022). Biologicals Market Report.
- EvaluatePharma (2022). Annual Forecast of Biologics Prices and Market Shares.
- Centers for Medicare & Medicaid Services (CMS) (2022). Reimbursement Policies for Biologics.
- McKinsey & Company (2022). Biologics Competitive Landscape Analysis.
